A double-blind randomized placebo-controlled trial with short-term beta-glucuronidase therapy in children with chronic rhinoconjunctivitis and/or asthma due to dust mite allergy
Galli, E.; Bassi, M.S.; Mora, E.; Martelli, M.; Gianni, S.; Auricchio, G.; Arabito, E.; Rossi, P.
Journal of Investigational Allergology and Clinical Immunology 16(6): 345-350
2006
ISSN/ISBN: 1018-9068 PMID: 17153881 Document Number: 604398
Background: Enzyme potentiated desensitization, in which beta -glucuronidase (BG) is administered with low doses of mixed allergens, was proposed in the 1970s for specific immunotherapy. The BG currently commercially available in a purified and standardized preparation devoid of any allergen has been suggested as a regulator in the allergic immune response, acting on the cytokine-network of type 2 helper T cells. A double-blind trial with a single dose of BG proved effective in preventing symptoms in adult patients with rhinoconjunctivitis due to grass pollen. Objective: The aim of this randomized double-blind placebo-controlled trial, conducted in Italy in 2004-2005, was to confirm the safety and effectiveness of double-dose intradermal BG immunotherapy in preventing symptoms in children suffering from chronic rhinoconjunctivitis and/or asthma due to dust mites. Method: We randomized 125 children with dust-mite related chronic rhinoconjunctivitis and/or asthma to the BG treated group (67) or the placebo group (58). All patients were screened before treatment (T0), at BG or placebo administration in October and February (T1 and T3), and at 3 and 9 months after T1 (T2 and T4, i.e. in January and June). Drug intake and bronchial, nasal and ocular symptoms were recorded in a diary. Results: Patients in both groups completed the study and BG treatment was well tolerated without side effects. Significant differences in symptoms were observed, in particular for conjunctivitis (P=0.008), which was less serious and more easily treated in the BG group. The total drug intake for allergic symptoms was significantly lower in the treated group than in the placebo group (P<0.01). Conclusions: BG immunotherapy is efficacious, safe, and well tolerated in allergic children. Moreover, good compliance with the administration of 2 doses per year and the lack of significant side effects makes the benefit/risk ratio of this treatment particularly favourable.